ANALYTICAL METHOD DEVELOPMENT AND METHOD VALIDATION IN PHARMACEUTICAL DOSAGE FORM

Abstract

As a part of thesis research work has been carried out on the pharmaceutical dosage forms. The pharmaceutical industry is an important component of health care systems throughout the world; it is comprised of many public and private organizations that discover, develop, manufacture and market medicines for human and animal health. Pharmaceutical dosage forms are a mixture of active pharmaceutical ingredient (API) and inactive substances (excipient). An active pharmaceutical ingredient is the substance in a pharmaceutical drug that is biologically active. Some medications products may contain more than one active ingredient. An excipient is generally a pharmacologically inactive substance used as a carrier for the active ingredients of a medication. In many cases, an quotactivequot substance may not be easily administered and absorbed by the human body; in such cases the substance may be dissolved into or mixed with an excipient. Excipients are also sometimes used to bulk up formulations that contain very potent active ingredients, to allow for convenient and accurate dosage. Based on the route of administration, and form of medication, different excipients may be used. newlineMajorly thesis research work has been performed on sophisticated analytical instruments like HPLC/UPLC that improve the analysis throughput and reduce product development cycle time.The separation is mixtures of various substances, are based on their distribution between a stationary and a mobile phase, which are present in a chromatographic column. The mobile phase moves across the column, in effect washing (eluting) compounds at a different retention time. These differences are achieved based on properties such as boiling point, polarity, electric charge (for ionic compounds) and size of the molecule. newlineHigh performance liquid chromatography (HPLC) has proven to be the predominant technology used in laboratories worldwide. By considering same the principles of HPLC and further adapted them to create ultra performance liquid chromatograph